Step-by-Step Completion Guide

Transcription

1 Step-by-Step Completion Guide For the NIHR CRN Industry Costing Templates Primary Care Version: May 2017 Page 1 of 37

2 Step-by-Step Completion Guide for the NIHR CRN Industry Costing Templates Document Control This document is issued and updated by the national CRN Coordinating Centre. Readers should ensure that the latest version is being viewed which is available on the Life Sciences Industry pages of the CRN website Document Information Document Title Step-by-step Completion Guide for the NIHR CRN Industry Costing Templates Primary Care Version May 2017 Supersedes April 2017 Function To support the use of the NIHR CRN Industry Costing Template Effective Date May 2017 Audience Category Expectation Purpose All users and reviewers of the NIHR CRN Industry Costing Template For Information Operational Supplementary information to support users to complete the NIHR CRN Industry Costing Template which describes each step required to populate the Industry Costing Templates while explaining the template functionality. May 2017 Page 2 of 37

3 Step-by-Step Completion Guide for the NIHR CRN Industry Costing Templates Contents 1. Getting Started 4 2. Using the template 7 3. Worksheet completion Information tabs 8 4. Worksheet completion Study tasks Worksheet completion Pharmacy Worksheet completion Medical Device Supply & Management Worksheet completion Set-up & all other costs Worksheet completion Summary Following completion Abbreviations 37 May 2017 Page 3 of 37

4 1. Getting Started The final or near final version of the Protocol or Clinical Investigational Plan should be used to complete the costing templates, which will reduce the requirement for updates and ensure all parties understand their responsibilities. The main sections of the Protocol or Clinical Investigational Plan used to complete the templates are the study design and schedule of Schedule of Events, often found as table within the Protocol or Clinical Investigational Plan outlining the activities and at which visits they are to occur.

5 Accessing the templates NIHR Website The NIHR website holds the master copies of the Industry Costing Templates. Each time you require a new template, please go to the website to ensure the most up-to-date version is used. This will avoid any potential re-work into a newer version and also minimise any corruption or errors that may occur when copying from previously completed versions. The NIHR website is made up of various sections and the tools relating to Industry studies are located in the Study Support Service section. This can be accessed directly via our dedicated URL and then by accessing the sections below. From the Study Support Service pages, click the Early contact and engagement button Within this section click on the blue text Find out more about the template and how it can help you

6 Downloading the templates The templates are created in Excel so the files will need to be downloaded and saved for entering the study specific information. There are three types of Industry Costing Template available to use depending on the type of study: Drug based, observational and/or medical device based studies in secondary care sites Drug based or observational studies in primary care sites Device based or observational studies in primary care sites The links to these templates are located on the costing page of the website: Double click the title of the template required shown as a red link and select open in the file download box that appears. Once the template is open, the file will need to be renamed and saved in order to override the read only status of the template and enable study specific inputs to be saved.

7 2. Using the template Macro settings The template has a number of automatic features designed to save time when completing the template. In order for these to work correctly, please check the excel settings will enable macros to run before downloading the template file. The worksheet entitled about this template describes how to activate these should they not already be set-up. In Excel 2010, go to the developer tab on the menu ribbon and click on macro security which will open a pop up box where enable all macros can be selected. This will remove the protected view functionality and enable the template s automatic functions to run from the start. Older versions of excel will need to follow the instructions included in the template. Checking that the macro setting is activated If the macro setting is on, two pop-up boxes will appear when the excel file is opened; the first is a reminder to go to the website to download the latest version, and the second details the version of the template. The template consists of a number of tabs which display the detailed cost information that generates the final summary page for insertion into the relevant model agreement financial appendix. Each site will require its own template to ensure the costs are applicable to each site, however a master copy should be created initially for inclusion with the R&D submission of provided to the lead CRN representative if review is required prior to R&D submission. Instruction worksheets The templates contain two instructional sheets entitled about this template and terminology. These provide a useful reference guide to the costs in the template and for new users it is recommended that these are printed out for reference during the template completion. For some of the more frequently requested information, there are sections containing further information, or links to specific information which are denoted with the following symbol: i Multi-site, multi-arm studies One template should be generated per study arm to capture the relevant costs and display an accurate study total. The first template captures all study costs with the subsequent templates only including the per patient costs associated with that study arm.

8 3. Worksheet completion Information tabs Cover worksheet The cover provides basic information about the study contacts and is the same for all the costing templates. When costing a study for the first time, please complete the section to detail the company/sponsor contact information for cost queries and negotiation as highlighted by the arrow below. The site information will be added at a later date once the sites have been selected. The sign-off boxes do not need to be completed by the company/sponsor as they form part of the CRN check and NHS cost approval process. Complete the company/sponsor contact details section only Study Info worksheet The information included in this section will guide a number of the calculations within the template so this should be completed as fully as possible. This page is split into three main sections: 1. Study information This section requires the input of the study identification information such as title and Protocol or Clinical Investigational Plan number (including version) to correctly process the costing

9 template once submitted to the CRN. In addition, this section requests information regarding the NIHR CRN portfolio status so that the cost documentation can be assigned to the correct records in the NIHR systems. The information regarding the investigator and principal research site should be inputted if known, but can be added at a later date if unavailable. 2. Site and service requirements This section allows the site to be selected in order to apply the correct location multiplication factor (Market Forces Factor MFF) to the costs. As the costing template is built using one rate per task this national tariff accommodates the unavoidable location specific variances in costs. For the initial completion of the master template this should remain as BLANK SITES TO BE DETERMINED. Once the master template has been validated by the CRN, the drop down arrow can be used to create site specific version for each selected site and the value will be automatically shown in the red text box and through-out the template. Please select the Trust for which the Template will be negotiated and finalised: Please select a Trust from the drop-down menu below: 1 Market Forces Factor inc. MFF The next row down requires the number of subjects PER SITE to be included. At the initial completion an estimated number can be included to indicate the average expectation for a single UK site. The remaining lines contain directional questions dependent on the template selected for use to guide completion of the correct worksheets in the template. Please select Yes or No from the auto-selection box which appears when the cell is highlighted and follow the instructional text that appears to the right.

10 3. Costing elements This section helps to explain the costs that are used in the price calculations. It describes the hourly rates used for each staff type as well as describing the indirect costs values that are added to the direct staff time for each procedure. This section is locked and cannot be edited. The rates used within each template as displayed at the bottom of this section of the template in a table as shown in the example below:

11 4. Worksheet completion Study tasks Per Patient budget worksheet The activities listed in this section should come from the activities in the Investigational Plan from the Protocol or Clinical Investigational Plan. The layout allows the list of procedures/ investigations to be cross-referenced with the number of times they are performed at each visit, much like a schedule of events table. The most important rule about this section is that the table is pre-formatted to calculate the totals and therefore additional rows or visit columns MUST be added using the add procedure or add visit buttons to ensure the calculations work correctly. This per patient worksheet is split into two sections: one for procedures and one for investigations, but both use the same method to calculate the costs per patient: 1. Input the activity 2. Assign time (for procedures) or list price (for investigations) 3. Allocate the activity to the correct visits Use the following flowchart to determine if the task is a procedure or an investigation: YES Requires mainly staff time and minimal support equipment? NO Required for every patient at pre-determined time points? YES Include as a procedure on the Per Patient Budget NO (Variable timing or patient applicable) Include as a procedure on the Additional itemised costs worksheet Requires analysis using equipment? YES Required for every patient at pre-determined time YES Include as an investigation on the Per Patient Budget worksheet NO (Variable timing or patient applicable) Include as an investigation on the Additional itemised costs worksheet NO Include as a procedure

12 Procedures The procedures, activities or assessments undertaken by the research team for the care setting the template represents, are listed in the first table. Inputting a procedure from the list To select a procedure, click on the drop down box below the procedures section and select a procedure from the drop down list. It is useful to include the procedures in the order they appear in the Protocol or Clinical Investigational Plan schedule to ease review and cross checking. Once selected, click on the button marked Insert Procedure to the List

13 The template will automatically add this activity into the first available empty cell under the procedure section with average times for members of the research team routinely involved in this activity. NOTE: Not all procedures will automatically populate a time. Where required, please provide proposed times or contact your Lead site for estimated times assigned to the relevant research staff for each activity. Additional information can be found in the NIHR CRN Therapy Area specific procedure guidance available from the costing page of the website. Inputting a non-listed procedure If the study requires a procedure that isn t included in the dropdown list, simply click on an empty cell in the table and complete the information for the procedure. Adding extra lines Before adding a procedure, a blank row must be available to display the information. For the table of procedures to maintain its pre-populated functionality and calculate correct totals an additional row must be added using the add procedure row button at the base of the table highlighted by the arrow below. If the table is full, a row needs to be added before it can be populated with a new procedure otherwise this will be inserted outside of the table and not counted in the total. Two blank rows should be maintained in the table to ensure the automatic functionality can operate correctly. Button to add additional row

14 Assigning the times After completing the list of procedures, check that each procedure has assigned times by the relevant research professional who will be undertaking this activity. Be sure to carefully read the description of each research activity in the Protocol or Clinical Investigational Plan, as many procedures are required to be conducted by specific health care professionals. These values represent an average time and can be adjusted based on the intensity of the work required by the Protocol or Clinical Investigational Plan for example, informed consent in a vulnerable patient group may take longer than the template suggested time. Further descriptions or supporting information regarding timing adjustments can be found in the about this template tab and can be accessed directly by clicking on the relevant blue text links next to the information buttons. Allocating to visits After listing all procedures and associated times, these need to be assigned to the appropriate visit by placing a 1 in correct visit column to reflect the Protocol or Clinical Investigational Plan schedule of events. The visit column headers should be edited to reflect the visit names as per the Protocol or Clinical Investigational Plan for ease of review and cross-checking. Adding extra visits As per the procedure rows, extra visits can be added to meet the requirements of the Protocol or Clinical Investigational Plan. The columns also contain pre-populated formulas to ensure the correct total is calculated, therefore the Add Visit Column button above the table should be used to insert this column to maintain the correct settings. Manual insertion of columns will result in incorrect functionality and may affect the totals.

15 NOTE: A completely blank column (including visit title box) to the left of subtotal is required for the summary page tables to read and summarise the information correctly. This is already included on the master template as a hidden column. Button to add additional visits Cost calculation After listing all the procedures, assigning the relevant times and allocating to the correct visits the table will calculate the costs automatically. These can be found in the right of the table. Investigations Investigations are listed in the second table located below the first and work in the same way as the procedures. However, the display is slightly different as the costs for investigations already include staff time, therefore the time allocations are not displayed.

16 Inputting an Investigation from the list To insert an investigation, click on the drop down box and select an investigation from the list of routine research investigations. To add a selected investigation click on the button marked Insert Investigation to the List. The template will automatically add this activity into the investigations table in the first free row and will populate the standardised price for this work. Many of the listed investigation prices have been standardised for price consistency when costing commercial research. The recommended prices should be used unless the site presents a substantially different rate during negotiation. Sponsors are not obligated to accept this rate, but may want to evaluate how this activity compares to other NHS research sites to ensure fair value for money. Be sure to carefully read the description of each research activity in the Protocol or Clinical Investigational Plan, because the requirements and specification of the investigation described in the Protocol or Clinical Investigational Plan may be different from the site s routine operating procedures. These differences may be highlighted by the site during negotiation and may result in a change in the price. If a price is not proposed by the template this is usually because a standardised price is not available due to large variability across the NHS. Therefore a price will need to be identified for the template cost calculations by asking the site to propose a price for this work or utilising

17 the Sponsor s previous costing experience for the investigation. The online resource may provide useful information of what some investigations require. In addition, some investigations may be included in the NHS Payment system or National Tariff. Inputting a non-listed Investigation If a non-listed investigation is required, select other from the investigation list, click to insert and write in the investigation with a proposed a price. This price should reflect the investigation and staff time performance. Please note only the capacity building and MFF elements are added to the investigational costs. Adding extra lines Before adding an investigation, a blank row must be available to display the information. In order for the table of investigations to maintain its pre-populated functionality and calculate correct totals an additional row must be added using the add investigation row button at the base of the table highlighted by the arrow below. If the table is full, a row needs to be added before it can be populated with a new investigation otherwise this will be inserted outside of the table and not counted in the total. Two blank rows should be maintained in the table to ensure the automatic functionality can operate correctly. Button to add additional row Allocating the visits After listing all procedures and associated times, these need to be assigned to the appropriate visit by placing a 1 in correct visit column to reflect the Protocol or Clinical Investigational Plan schedule of events. This is the same as for allocating activities to visits as in the procedure section. Any additional visits added to the procedure table will be automatically reflected in the investigation table to enable the correct assignment of the investigations to the corresponding visit.

18 Cost calculation After listing all the investigations, assigning prices and allocating to the correct visits the table will calculate the costs automatically. These can be found in the right of the table. Total per patient budget The combined per patient budget reflecting both procedures and investigations can be reviewed at the bottom of the worksheet page. Totals are captured for each staff category for procedures and investigations as well as being broken down into totals for each visit. The final section in the bottom right shows a summary of the per patient budget, including indirect costs, capacity building and the MFF. Subtotal costs - Per Patient Budget : Subtotal Indirect Costs : Subtotal Capacity Building : TOTAL Per patient budget including all Costing Template Elements : 1, TOTAL Per Patient Budget for LEEDS TEACHING HOSPITALS NHS TRUST (inclusive of MFF) 1, Additional itemised costs worksheet Some costs associated with a clinical trial are not per patient costs, for example Investigator safety report review, or are dependent on results of other assessments. These costs can be captured in the Additional Itemised Cost worksheet to agree a price up front, should these assessments be required. This section is also used to capture one off costs or those not always associated with patient visits, for example support for monitoring visits.

19 Inputting an activity This worksheet uses the same principles as the per patient section. Before inputting an activity into this section, it needs to be defined as either a procedure (i.e. the cost will be determined by the staff time required) or an investigation (i.e. the price will be provided). This is done by selecting the correct category from the drop down menu. This feeds through to the summary page and is required to correctly display the activities. Select correct category Each activity can then include the description and time or price in order to calculate a total cost. It is often useful to include any payment conditions that are needed in this description, for example, if the study requires additional scans based on certain diagnostic findings in the study, a brief reference to that condition should be included here to aid review and application of the cost. Adding extra rows Like the per patient worksheet, the table is formatted to generate a total value. In order for the table to maintain its pre-populated functionality and calculate correct totals an additional row must be added using the add investigation row button at the base of the table highlighted by the arrow below. If the table is full, a row needs to be added before it can be populated with a new investigation otherwise this will be inserted outside of the table and not counted in the total. Button to add extra rows

20 Cost calculations The total costs of the additional activities are automatically calculated by the template and displayed in the right of the table. A summary of the total additional costs can be found at the base of the table. Subtotal costs: Subtotal Indirect Costs : Subtotal Capacity Building : TOTAL Additional itemised costs including all Costing Template Elements : TOTAL Additional itemised costs for LEEDS TEACHING HOSPITALS NHS TRUST (inclusive of MFF) NOTE: These costs will be displayed on the summary page, but additional descriptions may be required in the model agreement to agree appropriate invoicing mechanisms. A proposed structure for this appendix is available on the costing page of the website to support the efficient invoicing of these elements.

21 5. Worksheet completion Pharmacy Pharmacy worksheet This section captures any NHS Trust Pharmacy related costs for activities specifically as a requirement of the Clinical Trial i.e. those not normally occurring as part of routine operations for the Pharmacy. Therefore, if an activity is required by the Protocol or Clinical Investigational Plan or is not part of local routine procedures, then the cost needs to be accounted for in the Template. NOTE: For Primary Care sites, this section should only be completed when delivery of the study will be supported by a local Trust Pharmacy. If the General Practice is performing any IMP related task on-site these should be captured in the per patient or additional itemised cost sections as required. The Pharmacy tab of the Industry Costing Template is divided into five main sections: Set-up, management and close-down costs Per patient costs Variable costs Additional costs Assumptions and definitions Many of the activities in the Pharmacy section have been standardised so they can be included as per the protocol or technical manual. A breakdown of the charges for these activities is documented on the right hand side of the Pharmacy section, which reflects the layout of the per patient or additional itemised cost sections.

22 Set up, Management and Close down Fee The appropriate set up fee should be chosen according to the study design and entering a 1 in the relevant units required column: Simple dispensary-only study with no aseptic handling required is Pharmaceutical Type A Aseptic dispensing only study with no involvement of dispensary staff is Pharmaceutical Type B Study requiring both dispensary staff and aseptic dispensing staff is Pharmaceutical Type C [For relevant Advanced Therapies and Radiopharmaceuticals] Specialist Professions Preparation Type D If a trial requires specific pharmacy activities to be carried out by staff on a remote site which necessities training of staff, creation of files, holding of records on such sites, a standard rate is available to cover these costs and should be added per site. IMP Management fee The IMP management fee covers all the work the Pharmacy is required to do in relation to the IMP and is not directly linked to patient numbers, hence an annual fee structure is applied. A list of specific activities covered by the IMP Management fee can be found at the bottom of the Pharmacy worksheet page. While no two studies are alike, experience from clinical trial pharmacy staff has shown that a flat fee using an average time required is a best practice approach to meeting the varying needs and intensity of these ongoing tasks for each study. The IMP Management fee should apply from month of initiation visit to the month of the close out visit. If this is thought to be a year and a half then 1.5 units should be included in the units required column to enable the value to be prorated. The same format is applied to the Specialist Profession oversight fee for relevant advance therapies and radio pharmaceuticals.

23 Per Patient section The per patient sections are designed to capture the dispensing related activities for each visit. Visit columns can be added as per the per patient and additional itemised cost sections by clicking on the add visit column button. Up to five different study drugs or comparators can be incorporated to accommodate different dosing regimens. Click on the add # drug to input an additional compound or comparator. Button to add visits Buttons to add next drug or comparator per patient costs Insert study drug or comparator name INSIDE the brackets in the title above the per patient section to identify the relevant costs and ensure the correct formatting for the invoicing function (if applicable) The number of patients assigned to each study drug or comparator MUST be included at the bottom of the section to enable correct calculation of all relevant costs. Dispensing Input the number of dispensings per visit into the per patient section for the relevant study drug or comparator. This is the same as the process for including study procedures or investigations in the per patient cost section.

24 Aseptic Drugs If the study involves aseptic dispensing, input the number of aseptic dispensings per visit into the relevant per patient section for the study drug or comparator rather than the Standard agent dispensing time as per the line above. This is the same as the process for including study procedures or investigations in the per patient cost section. This will include a 60 minutes for the aseptic dispensing activity to reflect the additional work required INSTEAD of the standard 25 minutes in the line above. Controlled Drugs If the study involves dispensing Controlled Drugs, input the number of controlled drug dispensings per visit into the relevant per patient section for the study drug or comparator. This is the same as the process for including study procedures or investigations in the per patient cost section. This will include an additional ten minutes for the dispensing activity to reflect the additional work required for controlled drugs. Advanced Therapy Drugs If the study involves dispensing Advance Therapy Drug, additional preparation time may be required. Input the number of dispensing per visit into the relevant per patient section for the study drug or comparator. This is the same as the process for including study procedures or investigations in the per patient cost section. The time has been left blank to enable an accurate additional preparation time for the particular advance therapy drug to be included. Use of IVR/IWR for dispensing If the study requires the pharmacy staff to utilise an IVR or IWR system for dispensings of the study drug or comparator, input the number of dispensings where this will be required. This is the same as the process for including study procedures or investigations in the per patient cost section. This will include an additional ten minutes for the dispensing activity to reflect the additional work required to use the system.

25 IMP delivery If the Pharmacy staff are required to post or arrange delivery of the study s drug or comparator to the patient, input the number of dispensings where this will be required. This is the same as the process for including study procedures or investigations in the per patient cost section. This will include an additional 15 minutes to reflect the preparation work required. Per Patient Costs [Warfarin] Task Pharmacy Time +Add visit column+ Calculated payment based on time taken Additional Visit(s) Baseline Visit 1 Visit 2 Pharmacy arrangement of IMP delivery or posting preparation time to the patient Individual Patient drug accountability This will usually be required for most studies. Input the number of dispensings where this will be required. This is the same as the process for including study procedures or investigations in the per patient cost section. This will include an additional 15 minutes for the dispensing activity to reflect the additional work required. Per Patient Costs [Warfarin] +Add visit column+ Task Pharmacy Time Calculated payment based on time taken Additional Visit(s) Baseline Visit 1 Visit 2 Individual patient drug accountability time NHS prescription charge Guidance is provided at the bottom of the Pharmacy cost section to help you determine which study drugs or comparators this fee is applicable to. Input the number of dispensings where this will be required. This is the same as the process for including study procedures or investigations in the per patient cost section. This will include the additional fee into the total costs. This is a national rate and as such no indirect costs, capacity building or MFF are added to this cost. Our financial appendix suggested text available on the CRN website costing page provides wording around updating this charge on an annual basis. Per Patient Costs [Warfarin] +Add visit column+ Task Pharmacy Time Calculated payment based on time taken Prescription charge (English sites only) NUMBER OF PATIENTS FOR THIS DISPENSING 5

26 Variable costs This section is used to include additional fixed costs that may be required for the study. For storage of IMP an estimated minimum space of approximately 0.5m 2 has been assumed in the IMP management rate. However, if the study is predicted to have a large recruitment or a lot of IMP to store thus requiring more space, additional space needs to be provided by Pharmacy for which the host NHS Trust will charge. Any assumptions made in relation to this item can be captured in the assumption section at the bottom of the Pharmacy section. These costs need to be recovered and as such a requirement for additional space should be included here but including a 1 in the units required column. For waste disposal/imp destruction please note if the Trust is expected to dispose of any IMP waste different to the Trust s standard practice as this may affect the price. If in doubt, please consult with the site s pharmacy clinical trials team. These costs are captured here if known upfront or can be used as references values should the requirement emerge during the study conduct. Specialist storage and transportation requirements are included for use as require for advance therapy or radiopharmaceuticals. Additional costs This section capture costs for a number of activities which are difficult to approximate in advance of the study e.g. relabelling and releasing of IMP batch, extended working hours or out-of-hours work. However, all of these activities are work associated with conducting a clinical trial and are above standard every day practice. The details for charging and invoicing for these activities should be included in the financial arrangement section of the model agreement, however this section can be used to provide a cost guidance for these elements.

27 Cost calculations The summary on the bottom right hand side of the Pharmacy page displays the total costs calculated in this section. Pharmacy Service Totals Pharmacy subtotal (all fees and charges) 2, Subtotal Indirect Costs Element 1, Subtotal Capacity Building Element TOTAL Pharmacy costs including all Costing Template Elements 4, TOTAL Pharmacy Service Costs for LEEDS TEACHING HOSPITALS NHS TRUST (inclusive of MFF) 5, Assumptions and definitions When Pharmacy costs are generated, there are elements of the service that may not be defined and assumptions may need to be made in order to generate a cost. These should be detailed in this section to ensure both parties are aware of the assumptions associated with the costs within this section and provide clear justification for any future changes. Definitions of the services included in the Pharmacy line items or additional information to support the costing, e.g. prescription fee applicability, are included at the bottom of this section.

28 Pharmacy Support To ensure all the necessary information is available to the Pharmacy staff for effective Pharmacy set-up and accurate cost review, please utilise the local Pharmacy review resources available on our website Further recommendations regarding Pharmacy involvement in clinical trials can be found in the guidance document of The National Pharmacy Clinical Trials Advisory Group (NPCTAG) (a partnership group of the RPS). Please contact the NPCTAG for any general pharmacy advice related to clinical trials, contact details are available on the Royal Pharmaceutical Society website Pharmacy Definitions What is meant by dispensing? Specially purchased trial drug or IMP NHS prescription charge The basic principle of the Pharmacy costing template is that charges may be applied for all pharmacy trial-related activity which has been agreed (by the Costing Steering Group) to be over and above business-as-usual for a typical hospital pharmacy Dispensing one standard agent, Investigational Medicinal Product or NIMP on one occasion for one patient priced as average dispensing per drug. Dispensing and labelling of multiple strengths of the same NIMP/IMP for an aggregate strength should be considered as one dispensing time Where the trial requires a specific brand of drug to be used which is not standard of care practice for the NHS Organisation acting as the trial site (i.e. cannot be used in the NHS Organisation s/trust s routine care outside of the clinical trial) the Sponsor is expected to reimburse the cost of the drug if it cannot be used in the trial (for example the trial is terminated) or expires prior to use in the trial. This is supported by the model agreement termination clause 12 requiring the payment of all costs incurred. The current regulations state that the NHS prescription charge must be levied on all medicines dispensed to outpatients participating in clinical trials, unless there is a placebo treatment arm and Trusts are legally bound to collect these charges. - Prescription charges do not apply to hospital inpatients, to TTO supplies (on discharge), to any medicines administered to outpatients in the course of treatment on hospital premises or for any medicines supplied as part of a placebo-controlled clinical trial - Prescription charges do apply to day case patients Enforcement of regulations for hospital day case and outpatients is often a local decision by each Trust. For example, in some trusts the Finance Director may make a local decision not to charge if they believe that the costs of collection are likely to significantly exceed the value of charges to be collected. For Trusts whose policy is to comply fully with the Prescription Charge Regulations, it is legitimate for these costs to be re-charged to the sponsor. i What is the difference between extended working and out-of-hours working? IMP Management Fee Exemptions are comprehensively summarised at: Further information can be found on Page 31 of the R&D Forum s Guidance to Facilitate the Conduct of Commercially Sponsored Research in the NHS (Secondary Care) at Extended hours are defined as work added onto the normal working hours (09:00-17:00 Monday to Friday), but not necessarily starting in working hours, for example CT dispensing required on a Tuesday 17:00-18:30. Whereas out-of-hours work is defined as weekend work or late evenings not following on from normal working hours, for example CT dispensing on a Tuesday 20:00-21:30 or Saturday morning The IMP Management Fee is applicable to all studies requiring IMP management by an NHS Pharmacy. Full costs are chargeable unless Sponsor/CRO provide evidence and/ or information for specific Pharmacy requirements resulting in a suitable negotiated fee. Charged as an annual fee, which can be calculated pro rata as required, for the duration of the trial unless otherwise agreed and documented in the trial agreement. Stock checks are deemed part of routine standard practice, however any additional requirements (e.g. reporting or Company requested stock checks) may be charged as additional fees. Charged from month of site initiation visit to month of site close out visit The following activities are included in the Dispensing Fee: Prescription screening Dispensing & labelling Routine stock accountability Aseptic compounding incl. essential pre- and post-dose set-up and clean-down Dedicated consumables (costed per dose ) Randomisation of new participants if agreed as a pharmacy role The following activities are included in the Set Up and Close Down Fees: Review protocol Feasibility assessment Communication with the sponsor Participation in mandatory local review and approval processes Attendance at meetings & liaison with PI, Research Nurse, CRA Write bespoke SOPs, associated documents and worksheets Set up dispensing & stock control software systems and documentation Set-up electronic prescribing and Pharmacy systems, where applicable Set up supply systems Train all relevant Pharmacy staff, as required Review contract including pharmacy costing Close down The following activities are included in as IMP Management Activities: IMP receipt, ordering and returning (whether using manual or IVR/IWR systems) On-site or within Trust storage temperature recording and includes excursion recording (not independently chargeable). Provision of non-standard (i.e. bespoke company format) temperature reports will be chargeable as these such reports are not routinely provided by the NHS. Click here to return to the top click here to return to the top click here to return to the top 6. Worksheet completion Medical Device Supply & Management MedTech template only worksheet This worksheet is for completion for studies involving medical devices only and is split into similar sections to the Pharmacy template: Set-up, management and close down activities Other Supply or Device Management services Project resources to be provided to the site Set-up and close down activities As per the Pharmacy tab, the set-up costs are average times for three types of medical device studies. The appropriate set up fee should be chosen according to the study design and inserting a 1 into the units required column: A supply or device to be checked and reviewed only by the research team is Consultation Type A Consultation with only one Trust service support department or other provider (e.g., Medical Physics, Electrical Engineering, Lab Based Medicines or Other specialists departments or providers) is Consultation Type B Consultation with more than one department is Consultation Type C No consultation with research staff required is Consultation Type D

29 A description of the set-up and close down tasks included are described at the bottom of the worksheet page. Device Management activities This fee covers the initial and ongoing maintenance and management activities for the study research elements. A monthly fee is charged for the duration of the study to cover any trial supply, equipment or device maintenance or management activities that may be required for the study device. Details of the specific tasks included are located at the bottom of the worksheet page. The number of months should be included in the units required column. Other Supply or Device Management services Other services that are not captured in the costs above can be detailed in this section. A description of the activity and associated cost should be added to the white column as shown below to enable the calculation of the total cost which will include the MFF. Cost calculation As per previous worksheets, a total costs for the section is displayed in the bottom right and will display on the summary worksheet page. Supply or Device Management Service Totals Subtotal (all fees and charges) - Subtotal Indirect Costs Element - Subtotal Capacity Building Element - TOTAL Supply or Device Management costs including all Costing Template Elements - TAL Device or Supply Management Service Costs for BLANK - SITES TO BE DETERMINED (inclusive of MFF) -

30 Project resources to be provided to the site These items are provided to the site FREE-OF-CHARGE and will not be included in any calculations within the Template, but are included for reference.

31 7. Worksheet completion Set-up & all other costs Set-up and other costs worksheet This worksheet captures all remaining costs associated with conducting a clinical study and is split into three sections. Set-up, management and close-down fee The template display a total set-up value with a task breakdown to support transparency. Proposed default fees are included in the template: R&D fee. This is a recommended fee only and it is suggested that each site is contacted as soon as possible to understand the individual site fees. The value can be adjusted on this worksheet. Archiving Fee is usually a third party provided cost included for all studies where the Sponsor is not. A proposed fee has been included; however the site can be consulted to confirm the standard tariff for that location. In addition, the templates include the following proposed additional fees for inclusion where applicable: Chief Investigator Fee is included only when the CI is located at that site. Select yes from the applicable column to include this cost in the total. Category A or B amendment fee is included to detail the cost associated with an amendment upfront. As the number of amendments for a study is unknown at the costing stage, this usually is a no in the applicable column to exclude costs being added to the total. Selecting No to applicable at this stage does not prevent the cost being incurred at a later stage following an amendment. All costs are subject to MFF value and the total costs are displayed to the right of the cost section. Primary Care Patient Identification Centre (PIC) Costs This section captures costs for patient referrals and should be based on work performed. The tasks this cost covers are listed in the template and the CRN Primary Care speciality can help guide proposed values where required.

32 Add Additional Support Department Primary Care Participant Identification Centre (PIC) Costs Set-up fee per PIC Task Price Applicable Estimated number of identified patients Estimated number of identified patients that will be randomised TOTAL Price TOTAL Price including MFF NO - - Successful screening fee per randomised patient NO - - Please provide the maximum number of PIC sites for initial recruitment here - - Additional costs There are a number of additional costs associated with a clinical trial that need to be captured for an inclusive budget. These are detailed in this section of the template and the total cost is based on the number of visits per patient and the total number of patients. Details regarding the payment or invoicing method for these additional costs should be detailed in the model agreement financial appendix as appropriate. Additional costs Task Price Applicable Total number of visits per patient Total number of patients TOTAL Price TOTAL Price including MFF Refreshments for Patients (applicable for visits lasting over 3 hours) NO - Refreshments for Carers (applicable for visits lasting over 3 hours) NO - Inconvenience payment for patients as agreed by ethics NO - Maximum patient travel costs per visit NO - Expenses for chief investigator attendance at Ethics meeting NO - - Refreshments Refreshments should be included for patients and their carers where applicable, if visits will last more than 3 hours. The value for refreshments should be included by the Sponsor. Inconvenience payments If the Sponsor wishes to include inconvenience payments to the patients, these should be detailed here. These fees should reflect the fees that have been agreed with the ethics committee. Travel Travel costs may vary from site to site due to their location. For example remote rural sites or inner city sites may require higher travel fees for their patients. Chief Investigator Expenses Where the Chief Investigator is based at the site, expenses may be incurred relating to attendance at the ethics meeting. These can be detailed here to ensure payment is via the employing organisation.

33 Fee definition At the base of the cost section is a description of each fee to provide further information on when the fee is applicable. i Fee Definition R&D fee Costing and model agreement negotiation across organisation for final agreement, including any sub-contracts/service level agreement/honorary contracts as required. Coordination of practical arrangements for confirmation of local capability and capacity across the organisation as required by HRA Approval. Further information is available in the CRN principles of good practice (link to be included to document). NOTE: Assessment is considered part of site selection and covered by the indirect and capacity building elements of the template. Research management activities, such as investigator file set-up and maintenance, including performance oversight for set-up and recruitment activities to deliver contracted requirements. Co-ordination of all close-down activities across the organisation to met Sponsor requirements. Provision of general support for Sponsor to understand organisation requirements in context of UK research environment. Local CRN team is available to provide support as required (link to contacts on website) Variations to value (increase or decrease) may occur in relation to study or therapy area complexity. Chief Investigator fee The Chief Investigator has additional tasks covered by this fee which are associated with: Ethics and MHRA review of documents Ethics submission Ethics meeting attendance Liaison with ethics assessment team Attendance at safety meetings throughout study Submission of Annual Progress Reports/ Development Safety Update Reports Provision of general medical oversight throughout the study including key teleconferences, Trial management, steering committee meetings to lead on study issues. Administration support time for activities listed above. If Chief Investigator involvement is only signature of Ethics form, this fee is not chargeable Further activities, especially prior to site selection, should be considered as a separate consultancy service which is not covered in this fee. A separate consultancy contract/costing is recommended. Activities deemed covered by indirect/capacity building elements To support the set-up costs included in the template, a list of items that are not chargeable as separate items has been included in the template. These costs are deemed to be covered elsewhere in the template, e.g. indirect costs/capacity building, and including these as separate line items may result in duplicated fees. i Activities deemed covered by indirect/capacity building elements of the template Non-chargeable tasks The following tasks are deemed as part of the business service and are considered included in costs already in the costing template and therefore are NOT independently chargeable: - Set-up of any finance and IT information systems as required - Invoice generation for all departments - Any standard tasks performed by the Trust as part of normal or routine patient care - Any trial related communications - Any standard administrative or management support and general maintenance of trial related paperwork (NOTE: this EXCLUDES data management) - Pre-site selection or feasibility tasks - Arrange/attend any introduction or qualification meetings - Time research time spend preparing or attending inspections by regulatory bodies - Time for any regulatory body inspections - Medical record retrieval - Internal contracts or paperwork for staff i.e. honorary contracts or University Trust agreements for research staff - PI duty of care responsibilities including Investigator review of safety reporting provided by COMPANY e.g. annual safety reports - Storage space/co-ordination of equipment/notes - Pre-screening (e.g. note searches) for non-stratified medicine/rare disease studies, however cost coverage for stratified medicine rare disease/study pre-screening resulting in significant workload for the participating organisation (e.g. data not recorded in routine patient notes) to be agreed on a study-by-study basis as required. - Company audits (if necessary Company and Trust can negotiate a cost for a company requested audit with above-standard time requirements for staff involved)

34 8. Worksheet completion Summary The summary worksheet pulls together all the costing information in the previous worksheets so that it can easily be reviewed and included in the model agreement. This page is locked and cannot be edited. Information pulls through from the study Info worksheet Variable/additional cost reminder for consideration in mcta Total cost summary Total cost summary for variable or additional costs The red text is a reminder that not all costs are displayed in the summary for example a fee may be agreed for a procedure, but that may only be performed at an unscheduled visit following the result of a previous assessment. As these cannot easily be predicted nor incorporated into the per patient budget, this text is a reminder to detail this information in the contract so the correct invoices can be generated and approved. The subtotal sections of the summary page cost summary (study costs, indirect costs and capacity build) do not include the additional itemised cost elements. These are only added to the TOTAL including all Costing Template Elements value is it will be unknown when these additional costs will apply.

35 Per visit costs NOTE: These tables can only be generated on a site specific template (i.e. site selected on the study info tab). If no site is selected (i.e. Blank-Sites to be selected) a run time error will occur. This can be rectified by including a site on the study information worksheet at the start of the template To the right of the summary table are two further tables (scroll across to column M) that can be used to tabulate the cost per visit for each patient. To create these tables, all information for the visits must be included in the per patient and additional itemised cost worksheets with a blank column (including visit name box) to the left to the subtotal section this enables the programming to pick up the visit names. Click on the calculate totals button and a table will appear to show the associated costs. These tables can be used in the model agreement to help with invoicing where required. Click on this button to create and populate the additional tables

36 9. Following completion Once the template is completed, it should be cross-referenced with the Protocol or Clinical Investigational Plan to ensure all procedures/investigations contained in the Protocol or Clinical Investigational Plan have been detailed for the corresponding visits. Please check that all additional non-visit related costs have also been included. CRN validation For CRN Portfolio studies, the Lead CRN will validate the costing template for the study. The validation ensures that all protocol required procedures, investigations and tasks are included in the template and highlights areas where additional activities may be required for inclusion to capture all the requirements for the site. The validation does not consider the price, time value or standard of care status for any study activities as this remains the responsibility of each participating organisation to consider during local capacity and capability activities. To gain the greatest benefit from this validation, ideally this occurs prior to HRA Approval submission (although it can be done in parallel) and is undertaken by the Local CRN area in which your Chief Investigator site is based. If you have not yet selected your Chief Investigator or lead site, this validation can be provided by one of the Local CRNs for any of the participating sites intended to be listed on Part C of your IRAS application for HRA approval. As list of the check performed by the Local CRN are provided on the NIHR website costing page. Site Negotiation Once you have your Initial Assessment Letter from the HRA the validated costing template is provided to the sites are part of the minimum document set to assess, arrange and confirm local capacity and capability. Each Trust is responsible for their own finances the NIHR CRN cannot enforce one price and therefore some element of local negotiation will be required to ensure the NHS Organisations meet the their obligations as outlined by the Department of Health. However, the negotiations should be minimised when using the costing template and any deviations justified by each site. The local site will contact the Sponsor directly to negotiate and agree costs. Following this agreement, the costing template should be appended by reference or included in full in the financial appendix of the relevant model agreement which is signed by both the Sponsor and Trust/site. There are some variable costs, for example out-of-hours work, that will need to be detailed in this section of the contract separately. The CRN provides a guidance format for this appendix on the NIHR website costing page. For the most effective approach to commercial research in the NHS, the NIHR CRN Industry Costing Template should be used in conjunction with the national model agreements for study contracts.

37 10. Abbreviations Term CRN CSP IMP IVR/IWR LCRN MMF NHS NIMP NIHR R&D Definition Clinical Research Network Coordinated System for Gaining NHS Permission Investigational Medicinal Product Interactive Voice Recognition/ Interactive Web Recognition Local Clinical Research Network Market Forces Factor National Health Service Non-Investigational Medicinal Product National Institute for Health Research Research and Development NIHR Clinical Research Network 21 Queen Street Leeds LS1 2TW Tel: Web: